Preoperative Biliary Drainage in Resectable Pancreatic or Periampullary Cancer

Trial ID or NCT#

NCT01774019

Status

not recruiting iconNOT RECRUITING

Purpose

The purpose of this study is to demonstrate that preoperative biliary drainage using self-expanding metal stents (SEMS) does not negatively impact overall surgical outcomes in patients undergoing pancreaticoduodenectomy for treatment of pancreatic or periampullary cancer.

Official Title

Randomized Multi-Center Study Comparing No Drainage to Preoperative Biliary Drainage Using Metal Stents in Patients With Resectable Pancreatic or Periampullary Cancer

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Age 18 or older - Willing and able to comply with the study procedures and provide written informed consent to participate in the study - Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and other periampullary cancers (histology not required) - Biliary obstructive symptoms or signs - Bilirubin level at/above 100 umol per liter (5.8 mg/dL) - Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy - Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least 2cm from the hilum - Patients deemed as resectable by pancreatic protocol CT or MRI - Surgical candidate per pancreatobiliary surgeon after multi-disciplinary discussion - Surgery intent within 4 weeks - Endoscopic and surgical treatment to be provided by same team
Exclusion Criteria:
  1. - Biliary strictures caused by confirmed benign tumors - Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and other periampullary cancers - Surgically altered biliary tract anatomy, not including prior cholecystectomy - Neoadjuvant chemotherapy for current malignancy - Palliative indication due to reasons other than surgical candidate status - Previous biliary drainage by ERCP/PTC - Patients for whom endoscopic techniques are contraindicated - Participation in another investigational trial within 90 days - Pregnancy
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Investigator(s)

Brendan C. Visser, MD
Brendan C. Visser, MD
Hepatobiliary surgeon, Pancreatic surgeon
Professor of Surgery (General Surgery)

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Contact

CCTO
650-498-7061

View on ClinicalTrials.gov